Usp 797 beyond use dating guidelines

We have dealt with this issue on several occasions previously on our website.The most comprehensive answer to the question is copied for you below.Previous inquiry submitted to Ask the Expert: Expiration of allergy extracts Question: We are expecting a Joint Commission survey sometime later this year.As a hospital-based Clinic, we were told that we are subject to the sterility requirements of USP 797, including the use of a laminar flow hood and PPE, which we comply with.This presentation looks at the differences between a manufacturer's expiration date and a sterile compounds beyond-use date (BUD). Hospital pharmaceutical services - Those characteristics include method of achieving sterility, if sterility testing is performed, and if a preservative is added. guidance on the requirements for compounding of medications, particular for CSPs. Regulations and Interpretive Guidelines for Hospitals. Thorough preparation combined with enhanced storage conditions (refrigeration and freezing) can dramatically increase the time that the CSP can be stored before administration. 5 ingredients of inappropriate quality in com- the achievement of sterility when compounding pounded sterile. The Guidelines For Pharmaceutical Sterile Preparations Aseptic.The revision will clarify that the beyond-use date (BUD) in the table “BUD by Type of Formulation” is specific for nonsterile preparations and users should refer to General Chapter Pharmaceutical Compounding—Nonsterile Preparations Revision Bulletin supersedes the currently official General Chapter.The Revision Bulletin will be incorporated in the Second Supplement to USP 37–NF 32.

Beyond use dates should be in accordance with the manufacturer's approved labeling.

Should you have any questions, please contact Rick Schnatz, Pharm.

D., Manager Compounding and Healthcare Standards (301-816-8526, [email protected]).

USP chapter 797, Pharmaceutical Compounding—Sterile. The storage time of the CSP must not exceed the original BUD even if the storage conditions change, such as storing a CSP at room temperature and then storing it in the freezer.

The ASHP Discussion Guide for Compounding Sterile Prepara-.


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